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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00051792
Other study ID # R21AT001168-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 16, 2003
Last updated August 16, 2006
Start date January 2003
Est. completion date July 2004

Study information

Verified date August 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of yoga in reducing shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in this study must have moderate to severe COPD and be primarily limited by shortness of breath.


Description:

Management of dyspnea (shortness of breath) is a major concern for patients with COPD. The efficacy of complementary exercises to manage dyspnea is unknown. Complementary exercises may be more congruent with patients' lifestyles and values than traditional exercise programs and can be adapted to changes in illness severity and disability. Yoga practice is a complementary therapy that people use to manage their dyspnea. The aims of this study are to: 1) develop a safe and feasible yoga program for patients with COPD; 2) test the efficacy of this program; and 3) determine whether physical performance, psychological well being, and health-related quality of life are positively affected by yoga practice.

Patients in this study will be randomized to receive yoga training or usual care for 12 weeks. Patients will be evaluated at study entry, after each session, and immediately after the training program.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion criteria:

- Able to commit to a 12-week yoga class in San Francisco, California

- Moderate to severe COPD, clinically stable for at least 1 month prior to study entry

- Forced Expiratory Volume at one minute (FEV1) < 49% predicted after inhaled bronchodilator

- Activities of daily living limited by shortness of breath

- Ability to speak English and sign consent

- Patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at > 85% on < 6 L/min of nasal oxygen

Exclusion criteria:

- Symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease, neuromuscular disease, psychiatric illness)

- Formal pulmonary rehabilitation training within 1 year prior to study entry

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
yoga


Locations

Country Name City State
United States University of California San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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